Pregnancy & Lactation: Risk data not available
What is Omidubicel?
Omidubicel is used in adults and children at least 12 years old with a certain type of blood cancer receiving a type of stem cell transplant to help increase white blood cells recovery and decrease the risk of infections.
Omidubicel may also be used for purposes not listed in this medication guide.
Warnings
You should not use omidubicel if you are allergic to dimethyl sulfoxide (DMSO), dextran 40, gentamicin, human serum albumin, or bovine products.
Tell your doctor if you have or have ever had:
- an antibiotic allergy; or
- kidney disease.
You may need to have a negative pregnancy test before starting this treatment.
Tell your doctor if you are pregnant or breastfeeding.
How should I use Omidubicel
Use Omidubicel (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets.
Omidubicel is given as an infusion into a vein. A healthcare provider will give you this injection in a medical setting.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
Using omidubicel may increase your risk of developing cancer and some rare genetic diseases. Ask your doctor about your individual risk.
Your blood will need to be tested often.
In a medical setting you are not likely to miss a dose.
Omidubicel side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.
A deadly condition called graft-versus-host disease (GVHD) may occur with omidubicel. You may receive medicines to suppress the immune system to lower the risk of GVHD. Tell your doctor right away if you have a rash, diarrhea, or yellow skin or eyes.
Another fatal disease called graft entrapment syndrome or graft failure can also occur with the use of omidubicel. Tell your doctor right away if you have unexplained fever, rash, difficulty breathing, or weight gain.
Common side effects may include:
- infections;
- graft-versus-host disease; or
- dizziness, nausea, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Omidubicel?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.